Z-2322-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2025
- Initiation Date
- July 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 453 units
Product Description
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Reason for Recall
Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.
Distribution Pattern
Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.
Code Information
UDI-DI: 15099590227173; Lot Number: 439163